- To determine the recommended phase II dose of hydroxychloroquine and carboplatin in
combination with paclitaxel and bevacizumab in patients with advanced recurrent
non-small cell lung cancer. (Phase I)

- To assess the antitumor activity, as measured by tumor response rate, of this regimen
in these patients. (Phase II)

Secondary

- To measure time to progression, progression-free survival, and overall survival of
these patients.

- To assess the incidence of toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study. This is a phase I, dose-escalation study of
carboplatin and hydroxychloroquine followed by a phase II study.

Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and
bevacizumab IV over 90 minutes on day 1 and oral hydroxychloroquine on days 1-21. Treatment
repeats every 21 days for a total of 4 courses. Patients then receive bevacizumab IV over
30-90 minutes every 21 days and oral hydroxychloroquine daily for up to 1 year in the
absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 6 months.

- No other active malignancy within the past 3 years, except curatively treated basal
cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or
ductal or lobular carcinoma in situ of the breast, or other curatively treated
malignancy with no evidence of disease > 3 years

- No retinal or visual field changes from prior 4-aminoquinoline compound therapy

- No known hypersensitivity to 4-aminoquinoline compound

- No known glucose-6-phosphate (G-6P) deficiency

- No known bleeding diathesis or coagulopathy

- No known gastrointestinal pathology that would interfere with drug bioavailability

- No known prior hypersensitivity to carboplatin, paclitaxel, bevacizumab,
hydroxychloroquine, or any of their components

- No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within the past 6 months

- No history of gross hemoptysis (i.e., bright red blood of a ½ teaspoon or more)
within the past 3 months

- No history of any social or medical condition that, in the investigator's opinion,
might interfere with the patient's ability to comply with the protocol or pose
additional or unacceptable risk to the patient

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- At least 2 weeks since prior radiation to sites other than the brain, and recovered
to ≤ grade 1

- At least 28 days since prior and no concurrent full-dose anticoagulants or
thrombolytic agents

- At least 28 days since prior major surgical procedure or open biopsy and no
anticipated need for such during study therapy

Location

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